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NDC 10129-0038-03 Perio Armor-X 1.7 g/100g Details
Perio Armor-X 1.7 g/100g
Perio Armor-X is a DENTAL; PERIODONTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Gingi-Pak a Division of the Belport. The primary component is HYDROGEN PEROXIDE.
Product Information
NDC | 10129-0038 |
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Product ID | 10129-038_e77bc6e7-de68-3e91-e053-2a95a90a96b2 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Perio Armor-X |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | 1.7% Hydrogen Peroxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | DENTAL; PERIODONTAL |
Active Ingredient Strength | 1.7 |
Active Ingredient Units | g/100g |
Substance Name | HYDROGEN PEROXIDE |
Labeler Name | Gingi-Pak a Division of the Belport |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2024-12-31 |
Package
Package Images



NDC 10129-0038-03 (10129003803)
NDC Package Code | 10129-038-03 |
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Billing NDC | 10129003803 |
Package | 1 TUBE in 1 BOX (10129-038-03) / 86 g in 1 TUBE |
Marketing Start Date | 2022-08-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e77bc6e7-de67-3e91-e053-2a95a90a96b2 Details
Indication and Uses
Directions
For children under 2 years of age, consult a dentist or physician before use. For adults and children 2 years of age or older: 1. Remove cap and cut the tip of the tube at the narrow end. 2. Apply several drops of the gel directly onto the affected area in the mouth. 3. Leave the gel on the affected area for at least 60 seconds, then spit. 4. Use up to 4 times daily after meals, at bedtime, or as directed by a dentist or physician.
Other Information
Inactive Ingredients
Warnings
INGREDIENTS AND APPEARANCE
PERIO ARMOR-X
1.7% hydrogen peroxide gel |
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PERIO ARMOR-X
1.7% hydrogen peroxide gel |
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PERIO ARMOR-X
1.7% hydrogen peroxide gel |
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Labeler - Gingi-Pak a Division of the Belport (008480121) |
Registrant - Jeff Nichols (008480121) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Gingi-Pak a Division of the Belport | 008480121 | manufacture(10129-038, 10129-039, 10129-042) |
Revised: 8/2022
Document Id: e77bc6e7-de68-3e91-e053-2a95a90a96b2
Set id: e77bc6e7-de67-3e91-e053-2a95a90a96b2
Version: 1
Effective Time: 20220830